Consumer Advocates Petition FDA to Ban Fibromyalgia Drug

Public Citizen, a Washington, DC-based nonprofit public health advocacy organization, petitioned the Food and Drug Administration (FDA) on Jan 20 to remove the drug Savella (milnacipran) from the market immediately. Savella was the third drug after Lyrica and Cymbalta to win FDA approval for prescription to fibromyalgia patients, in January 2009.

Savella acts to sustain levels of the important neurotransmitters serotonin and norepinephrine in the system, and has been approved in Europe and Japan since 1997 for treatment of depression and anxiety disorder.

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Following is Public Citizen’s press release on its petition, issued Jan 20:

“The fibromyalgia drug Savella should immediately be taken off the market because its dangers outweigh its benefits, Public Citizen said today in a petition to the Food and Drug Administration (FDA). The European regulatory authority, the European Medicines Agency (EMEA), rejected the drug’s approval for fibromyalgia in July 2009, stating that its benefits were “marginal” and “did not outweigh its risks.” This was shortly after the FDA approved the drug in January 2009.

Since the drug went on the market in the U.S., approximately 250,000 prescriptions have been filled, with doctors writing more prescriptions every month.

In two randomized clinical trials, Savella, also known by its generic name milnacipran, was found to increase blood pressure, heart rate and suicidal thoughts, Public Citizen’s petition said.

Among patients who had normal blood pressure at the beginning of the study, 19.5 percent of those who took Savella developed hypertension [high blood pressure], compared to 7.2 percent of those on a placebo.

“Because Savella is a drug that produces only a marginal effect on pain, the main problem for which patients seek treatment, and has the potential to be quite dangerous, it is clear that it should not be sold,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group.

“The FDA never should have approved Savella for fibromyalgia and should now immediately order the drug company to remove it from the market before large numbers of people suffer serious harm,” Wolfe said.

Based on the extent of increased blood pressure caused by Savella, the FDA medical officer who reviewed the drug estimated that persistent blood pressure hikes could increase the risk of a cardiovascular event (including death, myocardial infarction and stroke) by up to 50 percent.

Savella also puts patients at risk for other disorders, including seizures, addiction, excessive bleeding, mood disorders, fractures, glaucoma and gastrointestinal effects such as nausea and vomiting. In pregnant women, the drug also can lead to hazards for fetuses, newborns and nursing infants. Additional risks for men include testicular pain and problems with ejaculation.

The director of the FDA’s Division of Anesthesia, Analgesia and Rheumatology Products stated that although the dominant symptom of fibromyalgia is pain, the drug did not relieve patients’ pain in the clinical trials.

Fibromyalgia is a chronic disease, but neither of the drug’s trials showed any statistical effectiveness beyond three months. And even within the trials’ three-month duration, more than 90 percent of users in the trial received no benefit from the drug at all.

Although not marketed as an antidepressant in the U.S., Savella is sold in Europe and Japan as such. The drug is required in the U.S. to have the “black box” warning for antidepressants, which points out an increased risk of suicide in children, adolescents and young adults. Manufactured by Cypress Bioscience Inc. and Forest Laboratories Inc., Savella has been sold in the U.S. since May 2009.”

Does this mean Europe should no longer make it available for depression? It's listed side effects are common to several other anti-depressants and even other types of meds ie. for sinuses. That fact that it may only help a small portion of the patient populations still makes it worthwhile. Variety is good in medicine. The fact that there may be some dangerous side effects merely means that doctors have to do their job monitoring their patients. Mature patients know that ALL effective drugs have side effects. I fear an overreaction.

I understand that Savella is not for everyone, but I believe very strongly that it has helped me.
Let me get this straight--some people who have not been helped by Savella want to take it away from people who have been helped by it. Fascism, anyone?
Some people get a hot arm bump from flu vaccines and some people don't. Does this mean that the vaccines should be made unavailable for everyone?

So why is this group hitting on Savella only? Cymbalta is also an NSRI with all of the same potential risk factors and side effects. There is more than meets the eye in this formal request to the FDA. It wouldn't surprise me that the attack is being financed by Savella's competitors, especially since they are much bigger corporations than Cypress (who is a smaller European manufacurer) and have had a bigger political lobby footprint in Congress. Pharms have a history of knocking out the competition any way they can. And since the Bush Admin (and unfortunately continuing today in the Obama Admin) these companies will do anything and spend anything to eliminate their competition. Like everything else in this country money talks.
The arguments in the formal submission of this group could be made against the clinical findings of Lyrica and Cymbalta just as easily as they are being made against Savella. Before going on any drug, I read through the clinical trial results myself. I work in the medical field and understand the research environment. The Savella trial results track amazingly close to the moderate or should I say unremarkable results of Lyrica and Cymbalta. The side effects and risk factors are the same for all, and the post coordinate incidence of all three are the same. So what's the difference? The difference is that each person with FMS responds differently to different drugs, even within the groupings. So the more choices we have available, the more people can experience a better quality of life. That's the bottom line.
I run a Fibromyalgia support group. My advice to members is never take this kind of information at face value. Pharmaceutical companies will do anything to kill their competition, just as they will do anything to hide the negative aspects of their products until they are forced to take it off the market. Did you ever wonder why Vioxx was removed and Celebrex wasn't -there is no difference in their clinical profile and the risk factors are exactly the same.
I counsel my members to find something that works for them, understand the risks, weigh the side effects and then make informed decisions. I also counsel them to understand that these companies are in it for the biggest profit possible and will not act in the public interest. The FDA is still somewhat independent in that they have a strict methodology for dealing with post-coordinate incidence analysis. I strongly urge you to approach these scare tactics with a skeptical and measured eye, else you will just be another zealot drinking the corporate Koolaid.
Before throwing Savella out, ask yourself who is supplying the negative information? Follow the money.
Cathy McCarthy -NC

I am alarmed that because some people have reactions to a drug - they want to remove it from everyone.
I for one, have had wonderful success with Savella. I have been taking it since last July. Within days I felt like a painful tent had been removed from my body and I was able to actually have good days without pain. This has continued since then and I have a much better quality of life as a result of this medication.
Before I take any new medications, I weigh the benefits with the possible adverse reactions. I have fibromyalgia, psoriatic arthritis and psoriasis. The combination has given me enormous pain over the last 20 years or so. Each new medication that comes out has inherent risks associted with them, but the possibility of finding something to take away the pain is worth the efforts. I am on a biologic medication in addition to Savella, and it also has possible side effects. As an adult, I am the only one who should have the option decide if I want to try these drugs. If the reactions are worse than the pain, they I don't use them.
I get mild nausea from time to time with this medication, and I do keep an eye on my blood pressure just in case -but so far for me - I am doing well!
I don't want this medication removed from the market. Don't our voices count - those of us who are using this medication, and are finding pain relief??

I've been taking Savella for the last 8 months and have had positive results. It has helped reduce my overall body pain significantly. I've tried Cymbalta and Lyrica, and Savella is the only medication that has helped my fibromyalgia pain without bad side effects. I’m very concerned that Savella will be recalled and taken off the market.
I think everyone should have the chance to at least try Savella, while under the supervision of a doctor. I have sent a letter to Public Citizen telling them this and saying that Savella works for me.
I think a better solution than banning would be a stronger warning label and a long-term medical study to find out the long-term effects. These two actions would allow patients like us to continue to benefit from Savella and protect all of us from any long term side effects. What do you think about this proposal?
Just published a blog post with my email to Public Citizen, and details on how you can contact them with your Savella experiences.

The trials done on this drug, were only for a 3 minth period. It is very irresponsible to approve a drug that is for chronic pain without doing a prolonged trial. I was on Savella for about 6 months, and not until about month 4 did I start to see very scary side effects. I started to have a very high (135 bpm resting) heart rate and very bad palpitations. It lead me to my doctor whom prescribed it, who was unaware of this side effect, which to me is also irresponsible. I was put on Lopressor to lower my HR. It was suggested to me to see a cariologist, which I did. Mind you, I told both doctors that I believe it was the med causing it, whom were both pretty unaware. I had to wear a heart monitor for 24 hours which did show how bad my HR and Palpitatiomns were. I decided to wean myslef off this medication. As soon as I did so my HR went back to normal with no palps. If I did not take it upon myself to discontinue this med I could potentially have had major cardiac problems. I would do a lot of research before you take this medication. This is much more common than you would think. There are many stories online about the effects of this drug. Some not ending as positively as mine. The petition to take this drug off the market is definitely warranted. The benefits do not in any way outweight the risks. It causes hypertension very frequently also. Lastly I will tell you that I felt completely awful. Fatigued, heart racing and pounding constantly. I was extremely scared and thought I may have a heart attack and end up dead.

I also wanted to note that I was on Cymbalta for 4 years and had never experienced any effects to my heart. So for the person above, please do not compare these drugs as if they are the same. They are certainly not. Do your research on the effects of Cymbalta and you will not find anything that compares to the cardiac risks of Savella.